MAUDE Adverse Event Report: ARTHROCARE CORP. MINIMAGNUM KNOTLESS IMPLANT PKG; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	OM-2500
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was used in the procedure and while there continued to turn the wheel to inserted the anchor into the hole the line at the wheel broke also the suture cut too.There was not any pieces after procedure inside the patient and a backup device was available to complete the procedure with a significant delay.
Additional Manufacturer Narrative
The reported minimagnum knotless implant device, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual evaluation cannot be performed and customer¿s complaint cannot be confirmed.From the information provided, ¿device was used in the procedure and while there continued to turn the wheel to insert the anchor into the hole the line at the wheel broke also the suture cut too.¿ an exact root cause cannot be determined with confidence; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: incorrect suture used.Over tensioning.Device misalignment.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
The returned instrument, intended for use in treatment, was returned as an mdr for evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection of the om-2500 shows a deployed device with a suture lock button in its original state.The suture lock button is not pressed down.The snare line with loop is reeled into the wheel.The snare loop is intact.The implant is not detached.No suture is available.The instrument is not damaged as reported.There are no manufacturing abnormalities visually observed with the returned instruments.The magnum2 knotless is a single used device and cannot be functional tested.An attempt was made to test the basic functions of this instrument.The anchor could be detached by pressing down the suture lock button and by moving the lever.The complaint was not verified and the root cause could not be determined with certainty.Factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: improper suture loading, excessive tensioning or improper alignment of the inserter handle with the bone hole.The instructions for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that the device was used in the procedure and while they continued to turn the wheel to insert the anchor into the hole the line at the wheel broke and also the suture cut too.There were no pieces left inside the patient and a backup device was available to complete the procedure with no significant delay.

• Brand Name: MINIMAGNUM KNOTLESS IMPLANT PKG
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8060379
• Report Number: 3006524618-2018-00587
• Device Sequence Number: 1593287
• Product Code: MBI
• UDI-Device Identifier: 00817470005592
• UDI-Public: 00817470005592
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K042584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: OM-2500
• Device Lot Number: 1175424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 12/16/2018; 01/28/2019
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 12/17/2018; 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1